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(b)(4).Date sent: 06/24/2020.The dhr for lot 3700 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was received: what was the date of implant? we were only given the year of 2015.I believe it was (b)(6) 2015 - this was implanted at (b)(6).What is the lot number of the device that was explanted? lot# 3700, serial # (b)(4) model # ls14.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? i do not have access to those records.I believe they were completed at (b)(6).Besides dysphagia and pain, what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? patient is a (b)(6) y.O.Male with a previous history that includes severe gerd (s/p placement of linx esophageal sphincter magnetic device in 2015 at (b)(6)) who presents for evaluation of epigastric pain.Patient states that he first noted mild epigastric/substernal discomfort which began yesterday evening.It has remained constant since its initial onset.He states that the pain has progressively worsened since initial onset.He states that he called his gastroenterologist today who recommended that he present to the ed for further evaluation of possible complications related to the linx device.Patient describes the pain as constant, located in the epigastrium with radiation into his back and occasion radiation into his chest, "aching, gnawing, and boring" in quality, 8/10 in severity, with no particular provoking/exacerbating/remitting factors.It is not worsened with exertion.He did take famotidine earlier without significant relief.He denies associated fever, chills, palpitations, orthopnea, dyspnea, nausea, vomiting, melena, hematochezia, diarrhea, constipation, or urinary symptoms.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? he had one egd at this facility (b)(6) 2020 - no dilation.Egd with dilation (b)(6) 2015 at (b)(6).Please describe and include the dates of the procedures.(b)(6) 2020 - with the patient in the left lateral position in the and hooked up to cardiac and oxygenation monitoring a mouth guard was placed.An olympus gastroscope was introduced through the mouth guard into the oropharynx.It was advanced to the level of the esophageal opening with patient assisted swallows it was advanced into the esophagus.The esophagus was traversed and the scope was advanced through this area into the stomach.The stomach was insufflated with air and then the scope was advanced through the stomach into the antrum and through the pylorus into the duodenum.The scope was then backed up out of the duodenum into the stomach.The stomach was clean and visualization was good.The gastric antrum, gastric body and gastric cardia were all visualized.Retroflex view of the gastric cardia was also performed.The scope was backed up out of the stomach into the distal esophagus.A retrograde examination of the esophagus was then performed.The scope was removed and the patient was awakened and taken to recovery in stable condition.The procedure was well tolerated.There were no known complications at the time of the procedure.Findings: post linx changes at the ge jct.No erosion to explain the patients pain, however la grade a esophagitis noted.Approximately 2 cm of gastric mucosa above the linx pinch.Normal duodenum.Bx taken of the distal esophagus and mid esophageal body (b)(6) 2015 - (b)(6) - dysphagia post-linx magnetic sphincter placement.Dilated with decreased peristalsis.There was resistance to passage of the endoscope across the gej but no erosion of the linx device was seen.The gej was dilated twice; first we used the 20 mm tts balloon held in place for 60 seconds; then we used the 60 french savary dilator passed over a savary wire.There was a short tongue of columnar-lined epithelium extending just proximal to the gastric folds; this was not biopsied.How many beads eroded? the patient appeared to have a fair amount of inflammation in the tissues right at the hiatus, and i began dissecting in this area.The dissection was very tedious and slow secondary to the adhesions.I eventually, however, was able to separate the proximal stomach and esophagus from the crura circumferentially on the right anterior and left lateral aspects.However, during this period of time, with the amount of inflammation and scarring in this area, i had a general sense of where the linx device was, but i was unable to visualize it clearly, and i did not want to cauterize the areas blindly, at the point, dr lemieur perform upper gi endoscopy.Upper gi endoscopy actually revealed several linx beads within the esophagus.There appeared to be 4-6 of these, consistent with an erosion.I was, however, able to identify the inflamed capsule more clearly and see where the dissection needed to take place, and therefore cautery was used to dissect down onto the linx device.Anterior beads separated out the erosion.Appeared to be at the left lateral aspect right at the hiatus and right at the ge junction.The linx device was removed bead by bead.It was intact without any broken areas, although the suture holding it together appeared to have let loose.The linx was removed in its entirety and the beads were counted at 14.There appeared to be loops at each end consistent with removal of the entire device.Following this, i had an expected defect of tissue with an erosion-induced perforation at the ge junction.My plan was to make preparations for closure of this, but i needed to have some additional mobilization of the distal esophagus and stomach.Therefore, i mobilized the greater curvature by taking down the short gastrics.This also allowed for eventually a dor type fundoplication to buttress the primary repair.Once i had good mobilization, i was then able to primarily oversew the defect.It came together nicely.This was done using 3-0 polysorb.Following this, again, i used the dor fundoplication to bring tissue up and completely around, covering the esophageal erosion area.At this point, i had, again, dr.Lemieur perform upper gi endoscopy.We did leak testing while holding this area under saline.There were no signs of any bubbling.The repair was not stenotic, and we were able to get the scope through without difficulty, and then the scope was gradually backed up and removed.At this point, two 10 flat jp drains were placed in the upper abdomen.I did place these through two of my port sites, and these were secured in place.The remaining ports were then removed after pneumoperitoneum was evacuated.Wounds were closed with 4-0 vicryl in subcuticular fashion.Dressings were placed.He tolerated the procedure well.No noted complications.Was the patient stented? no.What is the current condition of the patient? developed complications leak/paraesophageal hernia.On (b)(6) 2020 and found no perforation or abscess but did note a sizable hiatal hernia / intrathoracic stomach with true paraesophageal hernia.He underwent egd, diagnostic laparoscopy with hiatal hernia repair, insertion of jp drain into the left chest.His stomach was tacked to abdominal wall and a percutaneous g-tube which was placed to both give traction to the stomach and allow for feedings if he developed stricture in recovery.Persistent (l) pleural effusion.Thoracentesis (b)(6) 2020, terminated for vasovagal episode.Thoracotomy (b)(6) 2020, pending outcome.When using the linx sizing device what technique was used to determine the size? we the retracted the liver with the liver retractor, and then began our dissection.We dissected first the lesser sac and the lesser omentum, and isolated and preserved the accessory left hepatic vein and vessel.We then took down the anterior attachments and the lateral to free up the esophagus and stomach from the hiatus.We left the phrenoesophageal ligaments intact except for the narrow area that we used for the sphincter just above the ge junction.We then isolated the posterior aspect of the hiatus and identified the right and left crus, and then used 2 stitches to close this defect.We did not use a bougie dilator during this part of the procedure.It was plenty loose when we were finished, with still adequate closure.We then dissected completely around the esophagus and then passed a penrose drain for retraction.We then dissected anteriorly and posteriorly and laterally to make sure there was extra fat.We identified the posterior vagus nerve and we separated it from the esophagus since it was not attached to the esophagus.It was in some fibrofatty tissue away from the esophagus and this would have affected of the size of the sphincter.Once we had isolated this, we then passed a penrose around the esophagus again to isolate the vagus nerve away from the esophagus.We then passed the linx sphincter into the abdomen.We brought this around the esophagus, and then, using a knot tyer and a clip, we tied this twice.Before we did this we used an esophageal measuring device to measure how many sphincter magnets we needed, and that with number was 14.We then tied the sphincter together with the knot tyers, and once this was finished we then evacuated the pneumoperitoneum and closed the incisions with 2-0 and 4-0 vicryl.The patient tolerated it well.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? i do not have access to those records, no indication in available notes.How severe was the dysphagia/odynophagia before intervention? i do not have access to those records, no indication in available notes.Were there any intra-operative complications during implant? none noted, body of operative report has been imported in linx sizing question.Was there any hiatal or crural repair done at the same time as the implant? there was a small hiatus hernia.We repaired this with 2 stitches and then placed 14-magnet sphincter in position around the esophagus.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? severe epigastric pain.
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